Is Big Pharma Slow Rolling Lung Cancer Care?
The term slow roll is a poker term used to describe a rude manuever by a Poker Player at the showdown. This occurs when a poker player knows that they have the winning hand, but takes their sweet time revealing the hand in order to embarrass the other player. Generally this is only done accidentally by novices, or by a poker player that wants to antagonize their opponent.
So why would a Pharma company do this?
Actually, there are several examples of Big Pharma companies doing exactly this tactic. Instead of immediately revealing some amazing benefits of their drugs to treat cancer, pharma delayed their FDA indications by years, and in some cases a decade! But Why would they do this?
Avastin/Tarceva combo for Lung Cancer: After over a decade of marketing both Avastin and Tarceva seperately for Lung Cancer,Genentech parent Roche revealed arguably the best data ever in a Lung Cancer study of the combination of these two therapies.
The data was first revealed in 2014 at ASCO, and it wasn’t until this year that the EU gave the combination an indication for EGFRmut driven lung cancer. There still isn’t an approval in the US where the slow roll continues.
Iressa for EGFRmut driven Lung Cancer: in 2003 AstraZeneca brought Iressa to the US market for 2nd Line Lung Cancer. In 2005, the drug was restricted on the market when it didn’t show survival data vs placebo in a follow up study. Then, a decade later, Iressa was reintroduced to the US market for the treatment of EGFRmut driven Lung Cancer. The crazy thing about this slow roll, was that Harvard researchers published data in 2004 which demonstrated the amazing benenfit of Iressa in these EGFRmut patients. So why did the Pharma company keep this from US patients for a decade? Why the slow roll?
Alimta and Non Squamous Lung Cancer: This is an interesting slow roll. Eli Lilly brought Alimta to market in the US in 2004 as a treatment for 2nd Line Non Small Cell Lung Cancer. Then, in 2008, Alimta received approval for non-squamous Lung Cancer in combination with another chemo agent in the frontline setting. What is interesting, is Eli Lilly slow-rolled the non-squamous info. In the 2004 indication, Alimta was indicated in all types of 2nd Line Non Small Cell Lung Cancer Patients. It took them four years to determine that the drug didn’t work in squamous patients and worked great in non-squamous patients?
In fact, Dr. Gaynor from Lilly proudly stated at ASCO 2008 that “histology matters”. Why didn’t it matter in 2004 when Lilly first received approval for Alimta? Don’t Squamous Lung Cancer Patient Lives Matter?
Opdivo for 1st Line Non Small Cell Lung Cancer: This slow roll is still in progress. What’s interesting is that Opdivo was launched in 2015 in the 2nd Line of Non Small Cell Lung Cancer by Bristol Meyers Squibb for all patients regardless of biomarker status. Then BMS tried for a 1st Line indication and failed to show a survival benefit vs chemo doublet in another broad population. Now the BMS CEO claims that the true benefit of Opdivo may be in a subset of patients with a high PD-L1 biomarker reading.
BMS feels that, while its study was risky, it has taken the high road in their Opdivo NSCLC studies. As the BMS CEO Giovanni Caforio told Matt Herper of FORBES:
“Our strategy in lung cancer from the very beginning has been to answer a number of questions in order to really understand how to treat every patient with lung cancer regardless of histology or PD-1 expression or line of therapy…And the trial tells us that the role of monotherapy is likely to be limited to a very small subset of patients that express PD-L1 at very high levels, which is what we believe we know from a previous study that was reported not a long time ago.”
Interesting that the “high road” in Pharma circles is the “slow roll” in other circles. Or maybe I’m confusing slow-roll with sandbagging? Either way, we’re going to have to wait years for BMS to demonstrate what they believe they know “from a previous study that was reported not a long time ago” that the true benefit of Opdivo rests in a biomarker limited population.
